Pfizer (finally) wins a big one with crizotinib approval for lung cancer

Proving once again just how eager the FDA is to see targeted cancer treatments hit the market, regulators announced late Friday they had issued an approval for Pfizer's non-small cell lung cancer drug crizotinib and a companion diagnostic 5 weeks ahead of their deadline. The approval marks a big win for Pfizer ($PFE), which has struggled for years to overcome setbacks in the clinic as generic competition prepares to storm the beaches of its Lipitor franchise. And priced at $115,000 for a year's treatment, the drug also underscores the arrival of a new generation of personalized cancer meds that come with a steep price tag.

Crizotinib--to be sold as Xalkori--targets a group of lung cancer patients with a particular mutation of the ALK gene. Abbott ($ABT) prepared the diagnostic that will be used to identify patients who can benefit from the drug. In clinical trials, investigators reported a response rate of 50% in one study and 61% in another. Anywhere from 1% to 7% of non-small cell lung cancer patients will have the abnormal ALK gene.

Bloomberg reports the average sales projection for crizotinib among four analysts is $540 million by 2015. Hoping to blunt criticism of the price, Pfizer also unveiled a plan to reduce co-pays to $100, with uninsured and under-insured patients getting the drug for free. The EU accepted Pfizer's marketing application for crizotinib about two weeks ago. And some analysts say the approval could mark the start of an important winning streak for Pfizer, which has been plagued by trial failures.

Bernstein's Timothy Andersen wrote Pfizer appears to be headed for 5 big approvals by the end of next year. "For a company that many, including ourselves, have viewed as the poster-child for inefficient R&D spending, this is a remarkable achievement assuming all goes as planned," he wrote, according to a column in Forbes.

"The approval of crizotinib is an exciting development. It further validates the idea that lung cancers are very different at the molecular level, even though they may look similar under the microscope, and should be treated accordingly," said William Pao, associate professor of medicine at the Vanderbilt-Ingram Cancer Center. "It also shows how fast translational research is becoming medical practice. ALK fusions in lung cancer were only first reported in 2007, and by 2010, we already had reports on the activity of a specific ALK inhibitor in patients with ALK fusion-positive lung cancer. Hopefully, this is just the beginning of many new benefits for lung cancer patients."

Pfizer's success follows closely on the heels of Roche's approval for vemurafenib, a melanoma drug tied to a companion diagnostic that warranted accelerated approval from the FDA. The agency has now approved 25 new drugs so far this year, compared with 21 for all of 2010. One of the big questions facing the drug development industry now is whether companies have actually figured out a better way to develop drugs with a higher likelihood of success or whether they're just experiencing a lucky streak that will evaporate next year.

- here's the FDA's press release
- get the story from Bloomberg
- check out the piece from Forbes